Are you pulling your hair out trying to engage and manage your clinical study safety committee members? If you struggle to coordinate meeting logistics with busy physicians located across the globe, suffer through lengthy and unproductive meetings, or have difficulty...
BRIGHT study leads are the best at what they do, and one reason is the support they receive from other team members. Like most clinical research organizations (CROs), we employ experts in study design, execution, and site management. In addition, we have dedicated...
A well-planned site selection process is essential for the smooth execution of your clinical study. How do you choose the best sites considering all the choices available? Do you need a key opinion leader (KOL) as your national principal investigator? Some sites are...
When bias creeps into a clinical study, the result can be a dubious reception by regulators and the scientific community. The solution is careful study design to minimize bias. In this blog post – a continuation of our series on common pitfalls in clinical study...
When you partner with experienced and capable investigators and research teams, you’ll be able to execute your clinical study in the most efficient and cost-effective way possible. At the other extreme are studies that get mired in the weeds of site bureaucracy and...
When a clinical study will be used to support an FDA market authorization application, it’s likely the agency will require a Bioresearch Monitoring (BIMO) inspection. Similar to our advice on clinical study design, it’s critical to “begin with the end in mind,”...
It may seem counterintuitive that collecting too much data is a common pitfall in clinical study design. After all, clinical studies are labor-intensive, time-consuming, and expensive, so why wouldn’t you try to get everything you can out of your study? In this blog...
Every medical device clinical study has endpoints, although they may be called something else, such as outcomes or metrics. Regardless of the name, we are talking about the objective, measurable results of a clinical study that are used to evaluate safety,...
When designing a medical device clinical study, if you don’t begin with the end in mind, you’re likely to encounter costly surprises during the study or in the subsequent regulatory application process. With patient safety, product success, and business objectives...